The BEPPO study is a Germany-wide clinical trial investigating whether a structured exercise program can improve physical and mental health in children and adolescents undergoing cancer treatment. Although exercise is known to support recovery and well-being, it is not yet a standard part of pediatric oncology care. The study aims to generate evidence to support the integration of exercise into routine treatment.
A total of 346 patients aged 3 to 18 years are recruited across 13 pediatric oncology centers in Germany. Participants are randomly assigned to either an exercise intervention group or a standard care control group.
Children in the intervention group take part in a 6-month individualized exercise program with 3-5 sessions per week. The program is delivered across different settings, including inpatient hospital care, outpatient treatment, and home-based training supported by telemedicine. This ensures continuous support throughout the course of medical treatment.
In addition to supervised exercise sessions, participants receive four structured counseling sessions. These sessions aim to strengthen motivation, address individual barriers to participation, and support long-term engagement in physical activity. The counseling also helps build a strong therapeutic relationship and promotes adherence to the program.
The exercise intervention is based on established principles of sports science but is individually adapted to each patient's health status, treatment phase, and personal preferences. Each training session follows a structured plan with specific goals, while also considering individual physical and psychological conditions to ensure safety, feasibility, and effectiveness.
The main objective of the BEPPO study is to improve physical performance, particularly leg strength, which is the primary endpoint. Secondary outcomes include endurance, functional mobility, balance, physical activity levels, fatigue, quality of life, mental well-being, frailty, and treatment-related symptoms and side effects.
In addition to clinical effectiveness, the study also evaluates how well the intervention can be implemented in routine healthcare settings. This includes assessing adherence, feasibility, and potential barriers and facilitators for integrating exercise into standard care. A health economic evaluation is also conducted in collaboration with health insurance providers to determine cost implications.
Overall, the BEPPO study aims to provide robust scientific evidence on the benefits and feasibility of structured exercise during pediatric cancer treatment. The long-term goal is to establish exercise as a standard component of supportive care in pediatric oncology, improving both short- and long-term outcomes for patients.
Patients aged ≥3 and ≤18 years
Oncological diagnosis with curative treatment intent
≤6 weeks since cancer diagnosis (diagnosis can be initial, secondary or relapse diagnosis)
Information and consent procedures feasible in German, English or with using local site resources (e.g., interpreters or multilingual staff)
Patients aged <3 and >18 years
No active medical oncological treatment (e.g., watch-and-wait strategy, surgery without ongoing oncological acute treatment at a pediatric oncology center)
Medical limitations that do not allow implementation of the study protocol
Life expectancy < 6 months
Parallel
Partially-standardised, supervised, continuity-of-care exercise intervention
BehavioralExercise sessions: 3-5x/week over 6 months (minimum of 78 sessions in total), duration: 30 minutes, partially-standardised with a primarily focus on strength and endurance exercises, additional components: coordination, flexibility, and balance exercises, supervised by exercise professionals, continuity-of-care achieved through hospital-based (in-patient/out-patient), and home-based online sessions Exercise counselling: 4x sessions in 12 months, family-centred exercise counselling, primary focus on understanding barriers and facilitators to physical activity and increasing intrinsic motivation for participating in the exercise session
Maximal leg extensor strength
Measured using a CITEC handheld dynamometer on the dominant side unless medically contraindicated. Patients are positioned prone with the knee flexed to 90°; if lying prone is not possible for medical reasons, the assessment is performed in a seated position. The dynamometer is placed anteriorly at the distal lower leg (shin). Outcome measure: maximal muscle strength (Newton; range 0.0-500.0). Interpretation: Higher values indicate greater muscle strength.
Maximal handgrip strength
Measured using a CITEC handheld dynamometer with a fist-grip applicator on the dominant side (unless medically contraindicated; in this case, the non-dominant side is assessed at all time points). Patients are seated with the elbow flexed to 90°. The dynamometer is placed in the patient's fist. Outcome measure: maximal muscle strength (Newton; range 0.0-500.0). Interpretation: Higher values indicate greater muscle strength.
Maximal dorsiflexor strength
Maximal arm flexion strength
Measured using a CITEC handheld dynamometer on the dominant side (unless medically contraindicated; in this case, the non-dominant side is assessed at all time points). Patients are lying down on their back with the elbow flexed at 90°. The dynamometer is placed at the patient's wrist. Outcome measure: maximal muscle strength (Newton; range 0.0-500.0). Interpretation: Higher values indicate greater muscle strength.
Sit and Reach Test (Mobility of the torso and lower back)
Measured using a Sit-and-Reach Box (Baseline). Patients are seated on the floor with their legs straight and their feet positioned against the box. The patient leans forward with both hands while keeping the legs straight, reaching as far forward as possible without changing the leg position, and moves the sliding device forward with the fingertips. The end position must be held for 2 seconds. No bouncing or jerking movements are allowed; only pain-free movements are permitted. Measurement is taken at the endpoint. Outcome measure: Forward lean in cm (Range: 6-59 cm). Interpretation: Higher values indicate greater flexibility.
Click on the lead sponsor to view all of their trials.
Universität Duisburg-Essen
Lead sponsor
University Hospital, Essen
Collaborator
University of Cologne
Collaborator
University of Regensburg
Collaborator
Klinik Hallerwiese-Cnopfsche Kinderklink
Collaborator
University Hospital Ulm
Collaborator
Klinikum Stuttgart
Collaborator
University Hospital, Bonn
Collaborator
Jena University Hospital
Collaborator
Universitätsklinikum Hamburg-Eppendorf
Collaborator
Johann Wolfgang Goethe University Hospital
Collaborator
Technical University of Munich
Collaborator
Children's University Hospital Cologne, Germany
Collaborator
Charite University, Berlin, Germany
Collaborator
Johannes Gutenberg University Mainz
Collaborator
University Hospital Cologne
Collaborator
AOK Rheinland/Hamburg
Collaborator
Techniker Krankenkasse
Collaborator
BARMER Krankenkasse
Collaborator
DAK Gesundheit
Collaborator
